WO2002085210A1

WO2002085210A1 - Urinary incontinence diagnostic system

Info

Publication number: WO2002085210A1
Application number: PCT/KR2002/000697
Authority: WO
Inventors: Yong-Gil Na; Kang-Hee Cho; Min-Cheol Whang
Original assignee: Yong-Gil Na; Kang-Hee Cho; Min-Cheol Whang
Priority date: 2001-04-23
Filing date: 2002-04-17
Publication date: 2002-10-31
Also published as: KR20020082053A; KR100421475B1

Abstract

The present invention relates to a urinary incontinence diagnostic system. In detail, it relates to a urinary incontinence diagnostic system that can be simply used in a primary hospital by introducing a urinary incontinence diagnostic instrument which qualitatively measures the conventional Q-tip test result to evaluate the over-mobility of urethra and, at the same time, measures bladder inside pressure and leak point pressure.

Description

URINARY INCONTINENCE DIAGNOSTIC SYSTEM

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a urinary incontinence diagnostic system. In detail, it relates to a novel urinary incontinence diagnostic system, which can provide an accurate diagnostic information for woman urinary incontinence patient and be conveniently used as a urinary incontinence diagnostic instrument for women at an ambulatorium of primary hospital .

Description of the Related Art

Urinary incontinence is a disease that urine leaks through urethra regardless of patient's intention. Even though the frequencies of incontinence are different, it has been reported that 30~40% of grownup women have experienced a urinary incontinence. According to a survey result on grown-up women residents in Jeongup and Ulsan area in Korea, it was reported that more than 50% of survey subjects had experienced a urinary incontinence. It was also reported that, by a survey carried out in Atlanta area in the United States, 20% of women of 35~69 ages were having urinary incontinence. Unlike a cancer or other consumptive diseases, urinary incontinence does not cause a serious effect on human-life. However, it brings an inconvenience, shame, and a restriction of social-life thereby. And thus, it could cause a serious mental problem. In addition, it often causes a dermatopathic disease and an economic load for its medical treatment. What is worse, in case that urinary incontinence is accompanied by fecal incontinence, a patient might be isolated from her family and hospitalized in a health- care system. Due to its harmful social effects as described above, urinary incontinence is often called as "social cancer".

Urinary incontinence is mainly classified into three different types: (1) Stress urinary incontinence, ( 2 ) Urge incontinence, and (3) Overflow incontinence.

(1) Stress urinary incontinence is the case that urine leaks involuntarily under the condition that abdominal stress is increased by coughing, laughing or playing a sport. It occurs because pelvic muscle becomes to be weak, urethra and bladder-caulis gets lowered, and therefore abdominal stress is not normally transferred to urethra and/or sphincter muscle of urethra becomes to be weak.

Pelvic muscle becomes to be weak mainly because baby' s head bursts some portion of muscle and/or ligament of pelvis during birth. Once some portion of muscle and/or ligament of pelvis are burst, urethra and bladder-caulis gets lowered, and/or pelvic muscle becomes to be weak gradually with the ages. Therefore, stress urinary incontinence often occurs after an asphyxial delivery and the frequency increases as she gets old. Additionally, stress urinary incontinence could occur after a uterine cancer surgery or a rectum cancer surgery. It also occurs to a woman having a congenitally short urethra or a woman having a nervous disease .

Stress urinary incontinence can be classified into two different types according to its cause. One is anatomic incontinence that is mainly caused by baby- birth during which pelvic muscle is weakened and urethra over-mobility is induced. The other is intrinsic sphincter deficiency that is caused by functional declination of urethra sphincter muscle regardless of anatomic dysfunction. For diagnosing stress urinary incontinence, a Q-tip test and other accurate examinations such as a urodynamic examination are required.

(2) Urge incontinence is the case that, when a patient having a brain disease, a nervous disease, or a urinary track infection, urine leaks by an involuntary contraction of bladder even when urine is accumulated only a little in her bladder. About 30% of women having stress urinary incontinence also have urge incontinence. The involuntary contraction of bladder can be detected by a urodynamic examination.

(3) Overflow incontinence is the case that urine overflows from an excessively expanded bladder. It occurs when the exit of bladder is narrow and/or the contraction power of bladder is weak. Prostate enlargement and urethra stenosis are common reasons for causing bladder exit to be narrow. Nerve injury, peripheral nerve diseases (diabetes , spine injury, etc), medicinal side-effect, and chronic constipation are the reasons for causing bladder contraction to be weak. Diagnostic methods for urinary incontinence are roughly classified into two types: (1) disease history hearing and physical examination, and (2) special examination .

(1) For hearing patient's disease history, first ask a patient when the urinary incontinence occurs among the cases when she feels a sudden urge to urinate and can not hold it or when she coughs or sneezes without having an urge to urinate.

In case that a patient has a disease such as multiple sclerosis, spine injury, spinal disk, peripheral nerve disease, Parkinson disease, or diabetes, urinary incontinence possibly occurs. And, urinary incontinence could also occur after uterine cancer surgery, rectum cancer surgery, or radiation treatment on pelvis. In these cases, ask her whether she is taking a menopause hormone treatment. And then, let her make a urine diary to hourly record her own daily urinating history such as number/amount of urination and incontinence, and check it by herself. In addition, let her drink a beverage of about 500ml, and after 15 minutes, let her do some activities which can cause urinary incontinence such as coughing, hopping, and so on, for about 45 minutes with wearing a pad. And then, by measuring the amount of urine on the pad, check the level of urinary incontinence.

Physical examination is carried out by laying a patient, having an appropriate urge to urinate, on a bed, letting her put stress on the lower abdomen, and checking the urinary incontinence. Next, perform a Q- tip test by using a cotton swap and observe inside her vagina ^"to check whether any prolapse of uterine, bladder, or rectum is occurred. During the procedure, also examine the tension/sensitivity of anal sphincter to check whether the nerve system works OK. (2) Special examinations include the following examinations :

• Urine test : Checking for cystitis.

• Measurement for residual urine amount : Measuring the residual urine amount in bladder after urination.

• Radiation/Ultrasonic examination : Observing the conditions of bladder and urethra during urination.

• Cystoscopy : Observing inside of bladder and urethra for checking any defect exists. • Urodynamic examination : Inserting a thin catheter into bladder through urethra, slowly injecting saline water into bladder until examinee feels an urge to urinate, and checking/recording the functions of bladder and urethra during urination. This examination has an advantage that it can obtain accurate biodynamic characteristics during the procedures of urine accumulation and urination.

For remedying urinary incontinence, medicinal treatment, pelvic muscle exercise, physical therapy (electrical stimulation, biofeedback, ExMI, etc.), and surgery (It is reported that organic function can be improved by surgery more than 85% recently.) can be applied. Among them, surgery is presently preferred in general, however, it is encouraged to begin with a non-surgical treatment as a primary treatment.

At present, however, a primary hospital is generally not equipped with a urinary incontinence diagnostic system by the reason that there is no simple instrument for urinary incontinence diagnosis. Thus, when a patient having a urinary incontinence visits to a primary hospital, a doctor simply listens to her disease history, tests physical examination, and gives her some medicinal treatment and/or exercising treatment thereafter. And, for taking some special examination, a patient has to be moved to the secondary hospital .

Most of present-selling urodynamic examination instruments are very expensive, and thus even a hospital with a urologist is hardly equipped with a full urodynamic examination system. In addition, since the conventional Q-tip test depends on subjective measurement performed by an examiner using a protractor, the measured data is not objective, and thus it is hard to establish a reliable database. SUMMARY OF THE INVENTION

The present invention is proposed to solve the problems of the prior art mentioned above. It is therefore the object of the present invention to provide a urinary incontinence diagnostic system that can be simply used in a primary hospital by developing a urinary incontinence diagnostic instrument which qualitatively measures the conventional Q-tip test result to evaluate the over-mobility of urethra and, at the same time, measures bladder inside pressure and leak point pressure.

To achieve the object mentioned above, the present invention presents a urinary incontinence diagnostic system comprising: a urinary incontinence diagnostic means for measuring angle and inside pressure of bladder; a diagnostic data acquisition means for analog/digital conversion, data input/output, data amplification, data transmission for analyzing and displaying; an analysis and display means respective for analyzing the values of angle and inside pressure of bladder measured by urinary incontinence diagnostic means and for displaying protocol information of the analyzed results of the measured value output from analyzing means.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating overall structure of a urinary incontinence diagnostic system in accordance with the present invention

FIG. 2 is a view illustrating an operation state of the urinary incontinence diagnostic section described in FIG. 1.

FIG. 3 is a view illustrating the inside structure of the urinary incontinence diagnostic device (Q-tip ) described in FIG. 2. FIG. 4 is a view illustrating an embodiment of measuring an angle at the light receiving panel of the urinary incontinence diagnostic section described in FIG. 2.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Hereinafter, referring to appended drawings, the structures and the operation procedures of the embodiments of the present invention are described in detail. FIG. 1 is a block diagram illustrating overall structure of a urinary incontinence diagnostic system in accordance with the present invention, FIG. 2 is a view illustrating an operation state of the urinary incontinence diagnostic section described in FIG. 1, and FIG. 3 is a view illustrating the inside structure of the urinary incontinence diagnostic device (Q-tip) described in FIG. 2. Referring to FIG. 1, a urinary incontinence diagnostic system in accordance with the present invention comprises: a urinary incontinence diagnostic section (100) for measuring angle and inside pressure of bladder; a diagnostic data acquisition module section (200) for analyzing the values of angle and inside pressure of bladder measured by urinary incontinence diagnostic section (100) - This section(200) has functions of analog/digital conversion, data input /output , amplifying data, data transmission for analyzing and displaying; and a analysis and analysis and display module Section(300) for hardware calibration, data analysis, database, patient analysis, and printing and for displaying protocol information of the analyzed results of the measured value output from a diagnostic data acquisition module section(200) - This section includes a software and a monitor.

Referring to FIG. 2, a urinary incontinence diagnostic section(lOO) in accordance with the present invention comprises: a light emitting panel (110) emitting light by using numbers of light emitting elements; a light receiving panel (120) receiving light emitted from the light emitting panel (110) by using numbers of light receiving sensors for angle measurement; and a urinary incontinence diagnostic instrument ( 130 ) for measuring inside pressure of bladder, wherein the light emitting panel (110) and the light receiving panel (120) are installed to be parallel to each other with a certain distance and the urinary incontinence diagnostic instrument ( 130 ) is placed between the two panels. Here, infrared light sensors are used for the urinary incontinence diagnostic section ( 100 ) .

A urinary incontinence diagnostic instrument ( 130 ) described in FIG. 3 is an instrument which improves a conventional Q-tip instrument. It has a novel inside structure fit for measuring pressure and angle. Looking into the detailed inside structure of the instrument, it comprises: a strain gauge(131); a guide rubber (132); a pressure balloon ( 133 ) ; a protective tape (134); a wire(135); and an outer case(13β). In other words, a thin-film-type strain gauge (131) is placed inside and the gauge is wrapped by latex to form a little balloon shape. The strain gauge (131) is made of a thin-film-type pressure sensor of which the internal resistance varies with the curved degree of the surface, and thus it causes a current change when it is being bent. The guide rubber (132) helps the gauge to be bent easily when pressurized. The pressure balloon(133) transfers pressure to the strain gauge (131) when the urinary incontinence diagnostic instrument (Q-tip) is pressurized. The protective tape (134) takes roles to lead the pressure to be concentrated on the sensor when the balloon shrinks inside and prevent the strain gauge being damaged while Q-tip is being inserted.

And the wire (135) is an electric wire transferring the current generated at the strain gauge (131) when the internal resistance of the strain gauge is changed by the strain.

Next, the operation characteristics and measurement principles, for measuring pressure and angle, of infrared sensors and the strain gauge of a urinary incontinence diagnostic system in accordance with the present invention are described in detail. First, looking into the procedures of angle measurement, it is performed by following the steps of locating a light emitting panel (110) and a light receiving panel (120) to be parallel to each other with a certain distance, placing a urinary incontinence diagnostic instrument ( 130) between them, and measuring an angle when the infrared light to be received by the light receiving panel (120) is intercepted by the urinary incontinence diagnostic instrument ( 130) . Here, the emission angle of infrared light is 30°, and the reception angle is 45°.

In other words, when infrared light is intercepted by the urinary incontinence diagnostic instrument ( 130 ) placed between the light emitting panel (110) and the light receiving panel (120), coordinates of the position of the intercepted sensor can be obtained.

An embodiment illustrating the measurement procedures is described in FIG. 4. In case that a urinary incontinence diagnostic instrument ( 130 ) is initially placed at a position a-b and replaced at another position a' -b' by the patient movement, the coordinates of (a,b) and (a',b') are obtained by the locations of intercepted sensors and the angle can be calculated thereby. A trigonometric function technique is used for calculating the value of measured angle. According to the present invention, when a urinary incontinence diagnostic instrument ( 130 ) is replaced to different position, the angle can be measured by using the moving distance, sensor position, and the coordinates before and after movement.

Bladder pressure measurement is carried out by using a strain gauge (131). Strain gauge (131) converts a strain, which is a microscopic physical phenomenon, into an electric signal so that the amount of strain can be measured.

Here, since the amount of resistance change generated in the strain gauge (131) is very small, Wheastone bridge circuit is introduced to improve the gauge efficiency.

Since Wheastone bridge circuit is made up of resistance, it can convert the resistance change into the voltage change. And thus, the strain can be measured by voltage measurement. Procedures for attaching a sensor to a urinary incontinence diagnostic instrument ( 130 ) , a Q-tip, is now described: 1. Take out a strain gauge (131) carefully by grabbing the matrix portion. If the iron portion is damaged, accurate value of strain can not be obtained. 2. Fix the strain gauge(131) by tape for attaching a wire to the gauge and cutting off the unnecessary adjacent matrix.

3. Cut off the matrix of the strain gauge(131). When cutting off, leave some portion of matrix about

0.5mm from the iron portion.

4. Put a little of gauge-bond at the end portion of the strain gauge(131) and attach a guide rubber (132) thereon by using a forceps. Here, prepare the guide rubber (132) to have an area a little smaller than that of the gauge and a length of about 5cm.

5. Cut off the accurate location, whereon the gauge is to be attached, of the catheter to be used as Q-tip.

6. Bond the gauge firmly on the designated location of Q-tip using a silicon material. Here, the gauge should be bond to be perpendicular to Q-tip on the exact location. 7. Pull the guide rubber (132) of the gauge forward to the front of Q-tip for the gauge to have some cover. And then, fix the guide rubber (132) on Q- tip by bonding.

8. Tape both sides of the gauge using general tape to prevent the gauge from being damaged by pressure. 9. Put paste around Q-tip for wrapping a water- resistant balloon on it.

10. Wrap a prepared latex material, which is prepared to have an appropriate size, around Q-tip to form a balloon shape.

11. Perform a water-resistant treat on the balloon.

12. Connect the wire (135), which is connected to the gauge, to an external board by using a connector.

Basic clinical research results on urinary incontinence diagnostic system in accordance with the present invention are as follows:

(1) Measurement system of a urinary incontinence diagnostic instrument using an infrared sensor:

After inserting a catheter into urethra and instructing a patient to have a cough, we measured the moving angle of the catheter by using panels on which infrared sensors are installed. Here, the measurement range of the panel was set to be 0°~90° and the moving angle was displayed on the monitor. Compared with that the conventional measurement method, in which an examiner reads a protractor to measure the angle, can measure the angle with an error bound of about 5°, the research results shows that the novel system using infrared sensor panels in accordance with the present invention measures the angle with an error bound of 1.25°. As a result, it can give more accurate and reliable results. In addition, for the cases of repeated measurement with the angle having a pre-set value of 30°, the angle was displayed on the monitor to be exact 30.0°.

(2) System for measuring bladder inside pressure and leak point pressure: In order to test the pressure measurement system developed in the present invention, a bladder simulator model was developed. The model is equipped with a catheter containing a pressure sensor using a strain gauge and a 10F double lumen urodynamic catheter, which is currently used in urodynamic examination, as a reference instrument. A 50cc injector is installed on top of the model to set a certain pressure. By connecting the two catheters installed at the simulator model to the pressure measurement system developed in the present invention and a conventional urodynamic examination instrument respectively, correlation between the two instruments along with the pressure change was examined.

Test result confirmed that there exits a correlation between the result of the novel pressure measurement system developed in accordance with the present invention and that of the conventional urodynamic examination instrument, DUET Urodynamic Testing System by Dantee Medical Ltd., used to be compared in the test.

(3) A comparative clinical experiment using a rabbit:

Biological experiment using a New Zealand White Rabbit was carried out. The weight of the rabbit was 2Kg~2.5Kg, and anesthetization was carried out by injecting Ketamine 3mg into the muscle. After dissecting the abdomen, a catheter was placed inside the bladder, and the bladder was stitched by suture. And then, after inserting a catheter of urodynamic examination instrument into the bladder through the urethra, a comparative experiment on bladder inside pressure and leak point pressure was carried out. As a result, we ascertained that there exits a correlation between the result of the novel pressure measurement system developed in accordance with the present invention and that of the conventional urodynamic examination instrument used to be compared in the test.

A measurement method for urinary incontinence diagnosis using a urinary incontinence diagnostic system in accordance with the present invention is now described in detail. After inserting a catheter through patient's urethra with the patient being laid on a bed, an examiner measures the movement and the pressure.

Here, examiner first measures the inside pressure of the bladder under the resting status, when patient feels an urge to urinate but holds it (in this case, urine volume accumulated in bladder is assumed to be more that 200ml in general) . Next, after letting the patient cough, the angle of Q-tip is measured repeatedly. And then, the highest value among the measured values is selected to be the result of Q-tip test .

Next, after giving some stress ( cough, valsalva pose, etc.) to the patient, examiner repeatedly measures the leak point pressure. The lowest value among the measured values is selected to be cough or valsalva leak pint pressure.

The measured results can be analyzed by the following indications : (1) The angle of Q-tip indicates the mobility of bladder-caulis and urethra. A severe movement (more than 30° in general) of bladder- caulis and urethra indicates the existence of anatomical dysfunction. (2) If bladder inside pressure is higher than a prescribed pressure ( 15cmH20) under resting status, it indicates the existence of bladder instability. In this case, under stress state such as coughing or valsalva pose, if leak point pressure is lower than 60cmH2O, it indicates an intrinsic sphincter dysfunction, and if leak point pressure is higher than 90cmH2O, it indicates an anatomic incontinence.

As mentioned thereinbefore, a urinary incontinence diagnostic system in accordance with the present invention has the following advantages:

A urinary incontinence diagnostic system in accordance with the present invention can be used for a screening test evaluating woman urinary incontinence at an ambulatorium of urology, gynaecology, and family practice .

In particular, it improves the conventional Q-tip test, which is mainly dependent upon subjective measurement, to be a quantitative measurement so that it can evaluate the over-mobility of urethra and, at the same time, measure the bladder inside pressure and leak point pressure. Moreover, it can also diagnose an urge incontinence accompanied to a patient having a stress incontinence, an anatomic incontinence, and an intrinsic sphincter dysfunction. Therefore, it makes it possible to diagnose a urinary incontinence patient without using an expensive urodynamic examination instrument . Consequently, it can be simply used for diagnosing a woman urinary incontinence at an ambulatorium of primary hospital. And thus, a patient can get an accurate information and appropriate treatment immediately without visiting to a big secondary hospital . As for a hospital, it also brings a positive effect because, even at primary hospital, doctors can diagnose urinary incontinence accurately by just equipping a low-price instrument. And thus, they can satisfy patient's request as well as create a new item for billing.

In addition, instead of improving the conventional Q- tip test, which is mainly dependent upon subjective and non-quantitative measurement, to provide a quantitative measurement information, it also provides a measurement information on bladder inside pressure as well as leak point pressure at the same time. Therefore, doctors can obtain useful information on woman urinary incontinence diagnosis without buying/using an expensive urodynamic examination instrument. Since those having ordinary knowledge and skill in the art of the present invention will recognize additional modifications and applications within the scope thereof, the present invention is not limited to the embodiments and drawings described above.

Claims

WHAT IS CLAIMED IS:

1. A urinary incontinence diagnostic system comprising; a urinary incontinence diagnostic means for measuring angle and inside pressure of bladder; a diagnostic data acquisition means for analog/digital conversion, data input/output, amplifying data, data transmission for analyzing and displaying; and an analysis and display means for analyzing the values of angle and inside pressure of bladder measured by said urinary incontinence diagnostic means and for displaying protocol information of the analyzed results of the measured value output from said analyzing means.

2. A urinary incontinence diagnostic system as claimed in claim 1, wherein said urinary incontinence diagnostic means comprising : a light emitting panel emitting light by using numbers of light emitting elements; a light receiving panel receiving light emitted from said light emitting panel by using numbers of light receiving sensors for angle measurement; and a urinary incontinence diagnostic instrument for measuring the inside pressure of bladder, wherein said light emitting panel and said light receiving panel are installed to be parallel to each other with a certain distance and said urinary incontinence diagnostic instrument is placed between said two panels.

3. A urinary incontinence diagnostic system as claimed in claim 1 or 2, characterized in that said angle measurement is carried out, when infrared light to be received by said light receiving panel is intercepted by said urinary incontinence diagnostic instrument, by obtaining the coordinates of the location of an intercepted sensor of said light receiving panel, wherein the emission angle of infrared light is 30°, and the reception angle of infrared light is 45°.

4. A urinary incontinence diagnostic system as claimed in claim 1 or 2, characterized in that the bladder pressure measurement is carried out by using a strain gauge that converts a strain, which is a microscopic physical phenomenon, into an electric signal for measuring the amount of strain; and the amount of resistance change generated in said strain gauge is measured by using a Wheastone bridge circuit .